AIM: To compare pain relief in patients randomly assigned to endoscopic ultrasound-guided celiac ganglia block (EUS-CGB) vs standard endoscopic ultrasound-guided celiac plexus block (EUS-CPB). METHODS: This is a single-center, double-blind, randomized parallel-group study to assess the efficacy of EUS-CPB vs. EUS-CGB in patients with painful chronic pancreatitis.
Inclusion criteria include: age\>18 yrs, ability for informed consent, chronic daily pancreatic-type abdominal pain. Exclusion criteria include: pregnancy, malignancy, recent acute pancreatitis (within 2 months), elevated INR (\>1.5) or low platelet count (\<75 cells/mm3), allergy to eggs or "caine" anesthetics.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
29
The intervention technique of EUS-CGB is the realization of EUS-guided celiac block with injection of bupivacaine directly into the ganglia for patients with chronic pancreatitis.
In the arm of EUS-CPB, the procedure is going to be performed with the standard EUS-guided celiac plexus block with injection of bupivacaine into the retroperitoneal space.
Cleveland Clinic Main Campus
Cleveland, Ohio, United States
Pain relief
The primary endpoint will be pain relief at 1 week after the block, defined as a decrease of 3 or more points in the VAS scale measuring "average pain over past week".
Time frame: 1 week
Complete response rate
Decrease in pain to 1 or 0.
Time frame: 1 week
Duration of pain relief
Duration of pain relief will be assessed during a 2-month follow-up.
Time frame: up to 2 months
Opioid consumption
Assess the opioid consumption in up to 2 months after endoscopic therapy.
Time frame: up to 2 months
Adverse effects
Assess the incidence of adverse effects after endoscopic therapy.
Time frame: in up to 2 months
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